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Prescription medicine · generic available

Tofacitinib

Brand names: Xeljanz, Xeljanz XR

Also listed by the FDA as: tofacitinib citrate · tofacitinib

Drug class: Janus Kinase Inhibitor

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

YesBoxed warning
None listedFDA shortage list
0Recalls (FDA reports)
29Companies
2012First FDA approval on file

Quick answers

What is Tofacitinib used for?
The FDA-approved label (Tofacitinib, Novadoz Pharmaceuticals LLC, September 1, 2026) says: “Tofacitinib tablets are Janus kinase (JAK) inhibitors. Tofacitinib tablets are indicated for the treatment of adult patients with: Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers. Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Tofacitinib have a boxed warning?
Yes. The FDA label for Tofacitinib has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Tofacitinib?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Tofacitinib been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Tofacitinib?
29 companies list prescription products of Tofacitinib in the FDA NDC Directory, including Pfizer Laboratories Div Pfizer Inc, U.S. Pharmaceuticals and Zydus Pharmaceuticals USA Inc..

What Tofacitinib is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Tofacitinib tablets are Janus kinase (JAK) inhibitors. Tofacitinib tablets are indicated for the treatment of adult patients with: Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers. Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers. …

— FDA label: Tofacitinib, Novadoz Pharmaceuticals LLC, effective September 1, 2026. Read the full label on DailyMed →

The FDA has 20 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Ulcerative colitisRheumatoid arthritis

Related medical specialties

GastroenterologyRheumatology

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

This label has a boxed warning. Read it on the full label →

18 of 20 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet, film coated · Tablet, film coated, extended release · Solution · Tablet, extended release · Tablet
RouteOral
Prescription products60 in the FDA NDC Directory
Brand namesXeljanz, Xeljanz XR

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Tofacitinib, by strength and form
Strength and formGeneric or brandPharmacies pay
tofacitinib 5 mg
tablet, film coated		 Generic $0.5619 per tablet
tofacitinib citrate 10 mg
tablet, film coated		 Brand: Xeljanz $103.94 per tablet
tofacitinib citrate 11 mg
tablet, extended release		 Generic $2.09 per tablet
tofacitinib citrate 11 mg
tablet, film coated, extended release		 Generic $2.09 per tablet
tofacitinib citrate 11 mg
tablet, film coated, extended release		 Brand: Xeljanz XR $207.90 per tablet
tofacitinib citrate 5 mg
tablet		 Generic $0.5619 per tablet
tofacitinib citrate 5 mg
tablet, film coated		 Generic $0.5619 per tablet
tofacitinib citrate 5 mg
tablet, film coated		 Brand: Xeljanz $73.77 per tablet

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA203214
XELJANZ		 Pf Prism CvNovember 6, 2012 29, latest September 16, 2026
2026: Labeling · 2026: Labeling · 2026: Efficacy
NDA208246
XELJANZ XR		 PfizerFebruary 23, 2016 16, latest September 16, 2026
2026: Labeling · 2026: Labeling · 2026: Efficacy
NDA213082
XELJANZ		 PfizerSeptember 25, 2020 9, latest September 16, 2026
2026: Labeling · 2026: Labeling · 2026: Efficacy

Generic approvals (23)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)1357541, 1741046, 2048566, 2273113, 2478433
SPL set ID of the quoted label253635c8-1ea7-41ba-b216-dea5e3305c47
FDA labels (SPL)20
FDA applicationsNDA203214, NDA208246, NDA213082, 23 ANDA
Active ingredients (FDA)TOFACITINIB

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Tofacitinib, Novadoz Pharmaceuticals LLC, effective September 1, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers